MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM PROX NECK TRL 40MM; FEMORAL TRIALS

Catalog Number 297531040

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that noticed instruments are broken upon inspection: 254401003 - broken/cracked plastic.254401006 - broken/cracked plastic.297531040 - bolt stuck, over tightened.

Manufacturer Narrative

Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information, which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained, that was not available for the initial report, a follow-up report will be filed as appropriate.D4 (expiration date).The expiration date (12/1/2099) submitted in the initial medwatch was reported in error.The device involved was an instrument and does not have an expiration date.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: it was reported that noticed instruments are broken upon inspection: 254401003 - broken/cracked plastic.254401006 - broken/cracked plastic.297531040 - bolt stuck, over tightene.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned device found that the prox neck locking bolt was jammed.The observed condition was most likely caused by overtightening or off axis assembly of the locking bolt.A functional test was performed and was able to replicate the reported jammed condition due to the device does not disengage as intended.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the reclaim prox neck trl 40mm would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use error.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: RECLAIM PROX NECK TRL 40MM
• Type of Device: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18356310
• MDR Text Key: 331067650
• Report Number: 1818910-2023-25536
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295156369
• UDI-Public: 10603295156369
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 297531040
• Device Lot Number: SO2006991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 01/05/2024; 01/12/2024
• Supplement Dates FDA Received: 01/08/2024; 01/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1